BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKS CUTTING FORCEPS

    MDR report key: 2446987 · Received January 27, 2012

    Report

    Report Number
    2183680-2012-00002
    Event Type
    Malfunction
    Date Received
    January 27, 2012
    Date of Event
    November 4, 2011
    Report Date
    December 28, 2011
    Manufacturer
    GYRUS MEDICAL INC
    Product Code
    GEI
    PMA / PMN Number
    K023492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFO FROM THE HOSP HAVE BEEN UNSUCCESSFUL, AND THE DEVICE HAS NOT YET BEEN RETURNED FOR EVAL. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFO BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPICALLY - ASSISTED VAGINAL HYSTERECTOMY THE CUTTING FORCEPS WOULD NOT COAGULATE. USED ANOTHER LIKE INSTRUMENT TO FINISH THE PROCEDURE. NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PKS CUTTING FORCEPS CUTTING FORCEPS GEI GYRUS MEDICAL INC 920005PK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1